On 12 August 2021, the Spanish Agency of Medicinal Products and Medical Devices (AEMPS) published a briefing note on the new regulatory framework applicable to antiseptics intended for the disinfection of the surgical site prior to surgery or to the injection point (“Briefing note“). Said products had been regarded by the Spanish regulator as biocidal products until the publication of a Resolution dated 2 June 2021 which reclassified them as medicinal products. Companies concerned by such regulatory amendment should note, however, that there is a transitional period so they will be able to adapt to the new requirements stemming from the classification as medicinal products: this transitional period will extend until 1 June 2022.
A closer look
Following the footsteps of other European authorities, last 2 June 2021 the Spanish Agency of Medicinal Products and Medical Devices amended the legal classification of antiseptics for use on human skin with the intended purpose of cleaning and disinfecting a surgical site or injection area.
Considering their use in a pre-surgery or injection context, these antiseptics can get into the body thus making likely the unfolding of unintended effects. To account for this, the AEMPS ceased to consider these products as biocides for healthy skin (as established in a previous note published back in 2011) and reclassified them as medicines.
This reclassification excludes, though, antiseptics for healthy skin merely intended for the surgical cleaning of hands.
Resulting from the amendment above, companies marketing these antiseptics face two major consequences which the AEMPS explains in-depth in its Briefing note:
- Product marketing authorizations. Companies shall have their antiseptics evaluated and authorized pursuant to the regulations on medicinal products (specifically Royal Decree 1345/207 of 11 October) before placing them on the market. In this sense, labelling shall also comply with rules applicable to medicinal products.
- Manufacturing requirements. Companies shall also obtain an operating permit as a manufacturer of medicinal products to be able to lawfully manufacture these antiseptics. To do so, they are required to follow the application process set out in Royal Decree 824/2010, which includes an inspection prior to the issuance of the authorization.
To streamline the transition and compliance with new requirements, the AEMPS granted companies a transitional period during which they will be able to market the relevant antiseptics which have been already authorized as biocidal products, ending on 1 June 2022.
In order to help companies navigate the new regulatory regime, the AEMPS has also published a Q&A section on its website. This includes valuable insights into the new regime. Namely, it clarifies that antiseptics covered by the regulatory change are not any antiseptic for skin disinfection or hospital use but only those intended for cleaning and disinfection of a site prior to surgery or an injection area. On another note, it clarifies that those products currently marketed as biocidal products that remain on the market beyond 1 June 2022 can be sold until end of stock.